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Title: Topotecan Approved in Europe for Treatment of Relapsed Small-Cell Lung Cancer

"Topotecan Approved in Europe for Treatment of Relapsed Small-Cell Lung Cancer"

NEW YORK -- May 13, 2008 -- Oral topotecan (Hycamtin) hard capsules have been approved by the European Commission for the treatment of relapsed small-cell lung cancer (SCLC). Specifically, topotecan hard capsules are indicated as monotherapy for the treatment of adult patients with relapsed SCLC (PS 0-2) for whom retreatment with the first-line regimen is not considered appropriate. The approval was based on positive results from a phase 3 study comparing topotecan hard capsules plus best supportive care to best supportive care alone in patients with relapsed SCLC, in addition to phase 2 and phase 3 supporting studies. In the phase 3 multicentre trial, 141 patients with relapsed SCLC not considered as candidates for standard intravenous therapy were randomised to receive best supportive care alone (n = 70) or topotecan capsules plus best supportive care (n = 71). Topotecan capsules added to best supportive care were associated with prolonged survival in patients with relapsed SCLC ([P = .0104, hazard ratio = .64). Median overall survival for topotecan capsules plus best supportive care was 25.9 weeks (95% confidence interval [CI], 18.3-31.6) compared with 13.9 weeks (95% CI, 11.1- 18.6), indicating a 36% reduction in risk of death for patients who received topotecan capsules plus best supportive care compared with patients who received best supportive care alone.

Supportive efficacy and safety data were provided from a phase 2 and a phase 3 study, each of which compared oral topotecan capsules directly with intravenous injection topotecan in patients with relapsed sensitive SCLC.

In the phase 3 study, median survival time was 33.0 weeks (95% CI, 29.1-42.4) in the oral group and 35.0 weeks (95% CI, 31.0-37.1) in the group given the intravenous injection. Both treatments were generally well tolerated. Safety data were presented for the 3 efficacy studies and for an integrated relapsed lung cancer study population of 682 patients. The safety profile was consistent across all 4 studies.

During the phase 3 study, the most common grade 3 or 4 toxicities with topotecan capsules were neutropenia, anaemia, thrombocytopenia, nausea, diarrhoea, vomiting, fatigue, and alopecia.

Topotecan is already available as an intravenous injection, so the approval of topotecan hard capsules provides physicians and patients with another treatment option.

SOURCE: GlaxoSmithKline Pharmaceuticals Europe

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